Spots Global Cancer Trial Database for Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

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Trial Identification

Brief Title: Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

Official Title: A Randomized Phase III Study of the Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation in Patients With Recurrent/Residual Small Hepatocellular Carcinoma (APROH Study)

Study ID: NCT01963429

Conditions

Recurrent Small Hepatocellular Carcinoma

Residual Small Hepatocellular Carcinoma

Interventions

radiofrequency ablation

Proton beam therapy

Study Description

Brief Summary: This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.

Detailed Description: The sample size for this study was based on a non-inferiority design. Primary objective: estimate local progression-free survival (LPFS) rate in two treatments Primary endpoint: 2-year LPFS rate Expected 2-year LPFS rate in the RFA: 85% Accural time and follow up time: 24 months and 24 months, respectively. Precision for 2-year LPFS rate estimation: Allowing a difference of 15% as the non-inferiority margin, with a power of 80% and a type I error level of 5%, evaluable 68 patients are required. Considering 5% of follow-up loss, we need 72 patients in each arm, so a total of 144 patients will be enrolled.